Perspectives on Properties of the Human Genome Project

Perspectives on Properties of the Human Genome Project

by F. Scott Kieff
     
 

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ISBN-10: 0120176505

ISBN-13: 9780120176502

Pub. Date: 12/31/2003

Publisher: Elsevier Science

The groundbreaking work of modern genetics that culminated in the Human Genome Project has blazed new pathways in both science and law. As the assertion of property rights generally, and patents in particular, has become increasingly common surrounding the new products and processes of modern biotechnology, the transactions that must occur for downstream research

Overview

The groundbreaking work of modern genetics that culminated in the Human Genome Project has blazed new pathways in both science and law. As the assertion of property rights generally, and patents in particular, has become increasingly common surrounding the new products and processes of modern biotechnology, the transactions that must occur for downstream research and development to occur have shifted in important ways, in both academic and business settings. Perspectives on Properties of the Human Genome Project addresses the problems raised in this complex area under different regimes of laws and norms to offer hope and help as we wrestle to ensure optimal use of such essential innovations. This unique collection of authors, views, and topics is essential reading for academics, policy-makers, and practitioners in medicine, biology, sociology, management, ethics, law, and economics, and anyone else interested in gaining perspective on the broad interface between biotechnology and property.

• Represents diverse views interwoven into a coherent dialogue
• Includes contributions from the leading thinkers in the field
• Explores the legal ramifications, in terms of property rights and patents, of the scientific developments arising from the work on the Human Genome Project

Product Details

ISBN-13:
9780120176502
Publisher:
Elsevier Science
Publication date:
12/31/2003
Series:
Advances in Genetics Series
Edition description:
New Edition
Pages:
538
Product dimensions:
1.38(w) x 6.00(h) x 9.00(d)

Table of Contents

Contributorsxvii
Acknowledgmentxix
Introductionxxiii
1Where We are and How We Got Here
1Patenting Life Forms: Yesterday, Today, and Tomorrow3
I.Introduction3
II.Patenting Life Forms4
III.What Happened Next?5
IV.What about Patenting Human Organs?8
V.Defining Human?9
VI.Epilogue11
2The Evolution of Gene Patents Viewed from the United States Patent Office13
I.Introduction13
II.Are Gene-Related Inventions Patentable Subject Matter?14
III.Utility of Gene-Related Inventions16
IV.Do Gene-Related Inventions Satisfy the Enable and Written Description Requirements?17
V.Novelty and Nonobviousness18
VI.Summary21
3Competition Policy in Patent Cases and Antitrust23
I.Introduction26
II.The Federal Circuit's Transformation of the Law26
A.Claim Construction26
1.The Governing Law Before Markman26
2.The Federal Circuit's Markman Decision27
B.Infringement by Equivalents and Prosecution History Estoppel29
1.The Governing Law Before Festo as to Equivalents30
2.The Governing Law Before Festo as to Prosecution Estoppel33
3.The Festo Decision35
4.Other Federal Circuit Efforts to Confine or Eliminate the Doctrine of Equivalents38
a.Specific Exclusion39
b.Foreseeability40
c.The Patent Specification Precludes Equivalence41
III.Competition Policy in the Treatment of Patents42
A.The Black/Douglas View of Patents in the Contex of Antitrust and Competition Policy in the 1940s and 1950s42
1.Patent Law43
2.Antitrust Law45
B.The Renunciation of the Black/Douglas View48
1.Economic Beginnings48
2.The Cases49
3.The Antitrust Division's View of the Role of Innovation in Competition56
IV.Precise Notice to Competitors and Rule of Reason Analysis under the Antitrust Laws60
V.Conclusion62
4Product Patents on Human DNA Sequences: An Obstacle for Implementing the EU Biotech Directive?65
I.Introduction65
II.Presumable Obstacles for Implementation67
III.The Case of Product Patents on DNA Sequences70
IV.The EU Biotech Directive in the Light of the Latest Scientific Developments74
V.Lessons to be Drawn from These New Developments76
5Patenting Genetic Products and Processes: A TRIPS Perspective79
I.The Uruguay Round of GATT Negotiations81
II.Article 27 of the TRIPS Agreement83
III.Interpretive Controversies and Political Fallout Likely to Arise out of Article 2787
A.Interpretive Controversies Concerning Article 2788
B.The Political Fallout Produced by Article 2793
IV.Conclusion: Implications for Human Genomic Research and Patent Protection95
6Enclosing the Genome: What Squabbles over Genetic Patents Could Teach US97
I.Introduction98
II.You Can't Own a Gene100
A.The Sacred101
B.The Uncommodifiable101
C.The Environmental Ethic102
D.The Common Heritage of Mankind102
E.The Rights of Sources103
F.Patentable Subject Matter104
1.Novelty104
2.Nonobviousness104
3.Utility105
G.Innovation Policy105
III.The Limits of Intellectual Property Policy106
A.The Bipolar Disorders of Intellectual Property Policy107
B.Reasons to be Narrow: Take 3110
IV.Reconstructing Scholarship113
A.Questioning and Refining the Ideal of Perpetual Innovation114
B.From Public Goods to Public Choice116
V.Conclusion118
2The Case for Property Rights
7Perusing Property Rights in DNA125
I.Introduction126
II.The Types and Rights of Ownership in DNA127
A.The Differences between These Types of Property127
B.The Interactions between These Types of Property130
III.The Object of Ownership in Patents135
A.The Rules about What is Not Owned135
B.The Rules about Disclosing What is Owned138
C.Applying These Rules to DNA140
IV.The Owner of Ownership in Patents142
V.The Implications of Ownership in Patents for Nonowners144
A.Ownership Operates Ex Ante to Bring Commercialization145
B.Transactions Operate Ex Post to Increase Output146
VI.Conclusion150
8Steady the Course: Property Rights in Genetic Material153
I.All-or-Nothing on Property Rights154
II.Moral Arguments against Property Rights in the Genome and Elsewhere156
III.The Common versus Private Property160
A.A Mixed Equilibrium160
B.Multiple Monopolies162
IV.Forced Transfers of Patent Rights168
A.Condemnation168
B.Compulsory Licensing171
1.Basic Proposal171
2.Mechanics of Compulsory Licenses175
V.Contracting Strategies179
VI.On to the Genome181
A.The Patent Law182
B.Express Sequence Tags188
VII.Conclusion193
9Varying the Course in Patenting Genetic Material: A Counter-Proposal to Richard Epstein's Steady Course195
I.Introduction195
II.Four Assumptions196
A.The Rational Patentee196
B.The Benign Patent199
C.The Malignant Compulsory License201
D.The Goals of Patent Law203
III.A Counter-Proposal204
10Reaching through the Genome209
I.The Old Model: Genes as Products210
II.The New Model: Genes as Research Tools213
III.Reach-through Strategies214
A.Reach-through Licenses214
B.Reach-through Remedies217
C.Reach-through Claiming218
IV.Normative Assessment of Reach-through Mechanisms224
V.Conclusion230
11The Human Genome Project in Retrospect231
I.Introduction232
II.The History, Structure, and Funding of the Human Genome Project234
A.A History of Private Challenges to the Human Genome Project235
B.Structural Options Considered at the Outset of the Human Genome Project236
1.One Agency238
2.Single-Agency Leadership238
3.Interagency Agreement and Consultation240
4.Interagency Task Force240
5.Consortium241
6.The Solution241
C.Funding Mechanisms242
1.Direct Appropriations and Government Contracts243
2.Grants to Individuals and Institutions244
3.Cooperative Research and Development Agreements244
D.Goals of Structure and Funding245
III.A Proposal for Administration of Science249
A.A Sketch of a Retrospective Grant Institution250
B.Refinements253
C.Objections256
D.Assessment of the Proposal258
IV.Conclusion260
12Goat-Boy Roams the Halls?263
I.Information and Advocacy of Reform263
II.Property Rights and Hybrid Regimes266
III.Goat-Boy Roams the Halls270
IV.A Final Adage270
13Comment on the Tragedy of the Anticommons in Biomedical Research271
14An Outsider Perspective on Intellectual Property Discourse275
I.Introduction275
II.Truthfulness/Completeness280
III.Typicality281
IV.From Theory to Practice283
V.Conclusion285
3Comparisons with Other Technologies and Other Legal Regimes
15Saving the Patent Law from Itself: Informal Remarks Concerning the Systemic Problems Afflicting Developed Intellectual Property Regimes289
I.Introduction289
II.Fallacy of the "All-or-Nothing" Approach291
III.The Semicommons as a Natural, Open-Source Community293
IV.From Semicommons to Anticommons: The Unbridled Proliferation of Exclusive Rights295
V.Database Protection or How to Elevate the Costs of Innovation Across the Entire Economy297
VI.Saving the System from Itself299
VII.A Comprehensive Solution301
16Biotechnology's Uncertainty Principle305
I.Heterogeneity in the Patent Law307
A.The History of the Uniform Patent System308
B.Biotechnology Patent Cases309
C.The Divergent Standards318
II.Modulating Technology-Specificity320
A.The Role of the PHOSITA320
B.Misapplication of the PHOSITA Standard325
C.Obstacles to Applying the PHOSITA Standard Properly328
III.Innovation, Invention, and Uncertainty334
A.Theories of Biotechnology Patents334
1.Prospect Theory334
2.Anticommons Theory339
B.Designing Optimal Biotechnology Policy344
C.Designing Optimal Pharmaceutical Policy350
IV.Conclusion353
17Commentary on the Panel Presentations355
18Commenting on Biotechnology's Uncertainty Principle361
I.The Written Description and Enablement Requirements361
II.The Nonobviousness Requirement363
III.The Obviousness Requirement and the Doctrine of Equivalents364
IV.The PHOSITA in Biotechnology364
V.Innovation, Invention, and Uncertainty366
19(Mostly) against Exceptionalism367
I.Introduction367
II.Adaptions versus Prescription: Exploring Technological Specificity and the Patent Law370
A.The Two Forms of Technological Specificty: Macro- and Micro-370
B.The Uncertain Effects of the PHOSITA372
III.The Hunt for Exceptionalism: The Technological Specificity of Parent Jurisprudence375
A.Patentability Jurisprudence375
B.Biotechnological "Jurisprudence"378
C.Reading the Cases: A (Brief) Response to Burk and Lemley379
IV.(Mostly) against Exceptionalism379
4Transactions Over Genetics in Academia and Business
20O Brave New Industry, That Has Such Patents in It! Reflections on the Economic Consequences of Patenting DNA385
I.Introduction385
II.Tool Companies and Their Business387
III.Vertical Disintegration of the Pharmaceutical Industry388
IV.Is the New Industry Structure Efficient?392
V.Concluding Thoughts396
21Pharmacogenomics, Genetic Tests, and Patent-Based Incentives399
I.Introduction400
II.Pharmacogenomics and the Promise of Customized Drug Therapy403
A.Genomics and the Practice of Medicine403
B.Genetic Testing Technology405
III.The Impact of Genetic Tests on Profit and Social Welfare in the Market for Existing Drugs407
A.The Basic Model407
B.The Information Content of the Test411
C.Tests with No Medical Value414
D.Differentiated Drugs in a Duopoly Market416
IV.Incentives to Conduct and Develop Genetic Tests419
A.The Incentive to Conduct Genetic Testing419
B.The Incentive to Develop Genetic Tests421
V.Conclusion425
22The Effect of Intellectual Property on the Biotechnology Industry427
I.Bringing New Drugs to Patients427
II.The U.S. Patent System: Promoting Innovation in the Biotech Industry430
III.Common Criticisms of Biotechnology Patents433
IV.Patent Policies Endangering the Biotechnology Industry437
V.Conclusion439
23Are Real Business People So Easily Thwarted?441
5Disputes over Genetics in Academia and Business
24One Size Fits All?449
25Some Empirical Evidence on How Technologically Complex Issues Are Decided in Patent Cases in U.S. District Courts459
26How Ordinary Judges and Juries Decide the Seemingly Complex Technological Questions of Patentability over the Prior Art471
I.Introduction: A Theory of Desert472
II.Novelty473
III.Nonobviousness476
IV.Conclusion482
27The Difficult Interface: Relations between the Sciences and the Law483
I.Introduction483
II.The Norms of Science485
III.Recent History492
IV.Fraud and the Law494
V.Remedies?504
Conclusion507
Index511

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